Executive Director, Global Regulatory Affairs CMC Early Development

3316 Takeda Development Center Americas•Boston, MA

12h•Hybrid

About The Position

Are you looking for a patient-focused company that will inspire you and support your career? Join us as Executive Director, Global Regulatory Affairs CMC Early Development (GRA CMC ED). Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As Executive Director, GRA CMC Early Development, you will provide strategic and people leadership to deliver innovative, compliant global CMC regulatory strategies and submissions for small molecule and biologic products through Phase 2 development. You will champion fit-for-phase CMC approaches that accelerate development while ensuring product quality, patient safety, and inspection readiness. A key element of this role is advancing the use of in silico approaches and digital innovation in CMC development (e.g., modeling/simulation, predictive tools, data and knowledge management, and digital CMC dossiers) to strengthen scientific justifications, enable right-first-time submissions, and improve speed and decision-making.

Requirements

Advanced degree in a scientific or engineering discipline (e.g., MS, PhD, PharmD)
20+ years of industry experience with significant experience in Global Regulatory Affairs CMC (or closely related CMC regulatory experience), including leadership for small molecule and/or biologic products in early development
Significant experience leading, reviewing, authoring, or managing CMC content for global regulatory submissions and responses in early development (e.g., pre-IND/IND, CTA/IMPD, amendments, briefing packages, and major deficiency responses) and negotiating requirements with health authorities
Strong working knowledge of small molecule and/or biologic CMC development and global regulatory requirements, including ICH guidance and regional expectations (FDA, EMA, MHRA, PMDA); experience across additional regions a plus.
Understands and interprets complex technical, nonclinical, clinical, and manufacturing issues across multiple programs as they relate to CMC regulatory requirements and strategy, including impurity risk, analytical control strategy, specifications, stability strategy, and comparability (as applicable).
Demonstrated ability to drive fit-for-phase global CMC regulatory strategy, leveraging prior knowledge, platform capabilities, and risk-based approaches; experience integrating in silico modeling/simulation and digital data strategies into CMC development and regulatory justifications is strongly preferred.
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
Demonstrated ability to think strategically and operate with increasing independence, understanding implications across the organization and globally; proactively identifies CMC regulatory issues and offers innovative, risk-based solutions and mitigation strategies.
Must work well with others and within global teams.
Able to bring working teams together for common objectives.
Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.

Nice To Haves

experience across additional regions a plus.
experience integrating in silico modeling/simulation and digital data strategies into CMC development and regulatory justifications is strongly preferred.

Responsibilities

Provides strategic leadership and development to global CMC regulatory subject matter experts to ensure innovative, robust, fit-for-phase regulatory strategies for small molecule and biologic products for FIH to pre-pivotal development, maximizing global regulatory success and minimizing time to clinical milestones.
Establishes best practices and a strong regulatory community across Global Regulatory Affairs and CMC functions (process development, analytical, formulation, drug substance/drug product, device/combination where applicable, quality, clinical, and manufacturing) to ensure consistent, high-quality execution.
Serves as an influential leader internally and externally, shaping early-development CMC regulatory policy, influencing cross-functional decision-making, and advancing adoption of in silico and digital approaches to product and process development across major regions (e.g., US, EU, Japan, China).
Leads and develops a team of regulatory leaders and subject matter experts, overseeing global CMC regulatory strategy and key submissions/health authority interactions for an assigned portfolio of small molecule and biologic products from FIH to pre-pivotal.
Partners with cross-functional leaders (CMC, Regulatory, Development, Clinical, Nonclinical, Quality, Safety, Manufacturing, Supply Chain, and Digital/Data) to align CMC development plans, to regional regulatory expectations and program timelines.
Ensures governance teams and key stakeholders are apprised of CMC developments impacting regulatory success (e.g., process/formulation changes, analytical readiness, control strategy evolution, comparability considerations, starting material strategy, impurity risk, raw material/supply risk).
Anticipates risks and drives mitigation plans consistent with quality risk management principles.
Represents Global Regulatory Affairs CMC in senior-level governance and in interactions with global health authorities, including FDA, EMA, MHRA, PMDA, and other agencies as applicable, to enable efficient pathways for early development CMC strategies and submissions (e.g., pre-IND/IND/CTA, amendments, Type B/C meetings, scientific advice).
Accountable for ensuring global CMC content quality and compliance for early development submissions and lifecycle changes through Phase 2 (e.g., IND/CTA modules, IMPD quality sections, amendments, investigator’s brochure CMC, and responses to health authority questions), partnering with regional leads and technical functions to ensure consistent, inspection-ready documentation.
Leads departmental and cross-functional initiatives to advance fit-for-phase and platform approaches in early development CMC, including global harmonization of templates and positions, improved knowledge management, and readiness for accelerated programs (e.g., breakthrough/PRIME/RMAT where applicable).
Provides CMC regulatory strategy leadership for business development and due diligence, including assessment of early CMC maturity, comparability risks, prior knowledge leverage, and global filing feasibility for small molecules and biologics.
Monitors and anticipates global regulatory trends impacting early development CMC (e.g., ICH Q12/Q13/Q14/Q2(R2), nitrosamines, elemental impurities, biologics comparability, emerging expectations for modeling/simulation and structured data), translating insights into proactive CMC development and submission strategies.
Champions use of in silico approaches and digital capabilities in CMC (e.g., predictive impurity risk assessment, process and formulation modeling, PBPK/biopharmaceutics linkages where relevant, digital data lineage, and content re-use) to improve scientific justification, reduce cycle time, and strengthen global regulatory interactions.
Responsible for demonstrating Takeda leadership behaviors.